University College Dublin
University College Dublin (UCD, www.ucd.ie) is one of Europe’s leading research-intensive universities, an environment where undergraduate education, masters and PhD training, research, innovation and community engagement form a dynamic spectrum of activity. Since its foundation, the University has made a unique contribution to the creation of modern Ireland and is currently ranked within the top 1% of higher education institutions world-wide. UCD is also Ireland’s most globally engaged university with over 38,000 students drawn from 152 countries, including over 5,000 students based at locations outside of Ireland. It is Ireland’s largest university, and with its diversity of disciplines, UCD embraces its role to contribute to the flourishing of Ireland through the study of people, society, business, economy, culture, languages and the creative arts, as well as through research and innovation.
The UCD team is led by Professor David Brayden, Professor of Advanced Drug Delivery,
(https://people.ucd.ie/david.brayden). It has an international reputation in non-invasive administration of peptides and proteins, especially by the oral route. He is the coordinator of BUCCAL-PEP and runs a team of PhD and postdoctoral scientists funded by the EU. The main tasks of UCD in BUCCAL-PEP are to contribute research to the design of the BUCCAL-PEP patch, to carry out flux studies across isolated porcine buccal tissue and in vitro cell-based models, to manage the overall budget, to project manage BUCCAL-PEP with the Catalyze partner, and to manage curation of project data.
Professor David Brayden is also a funded investigator at CÚRAM, Science Foundation Ireland Research Centre for Medical Devices, a world-leading Irish Medical Device R&D Centre based out of University of Galway.
Prof. David Brayden, Project Coordinator
Prof. David Brayden is Full Professor of Advanced Drug Delivery at University College Dublin School of Veterinary Medicine and also a Senior Fellow of the UCD Conway Institute. Following a Ph.D. in Pharmacology at the University of Cambridge, UK (1989), and a post-doctoral research fellowship at Stanford University, CA (1991), he set up Elan Corporation’s pharmacology laboratory in Dublin (1991). At Elan, David became a senior scientist and project manager of several of Elan’s Joint-Venture drug delivery research collaborations with US biotech companies. In 2001, he joined UCD as an Assistant Lecturer and was appointed Senior Lecturer (2005), Associate Professor (2006), and Full Professor (2014). David completed a Principle Investigator Grant from Science Foundation Ireland (SFI) on oral delivery of mucoadhesive polymeric peptide conjugates (2005-2009). David was the Director of an SFI Research Cluster grant (The Irish Drug Delivery Research Network) from 2007-2013. He was the Deputy Coordinator of an EU 7th Framework grant on oral nanomedicines (www.TRANS-INT.eu ), 2012-2017. From 2014-2021, he was a Principal Investigator on the SFI Centre in Medical Devices (CURAM), which was renewed in 2021 (www.curamdevices.ie).
He is the current coordinator of BUCCAL-PEP, an EU Horizon Consortium working on buccal peptide delivery (2023-2026). David is the author or co-author of more than 300 research publications and patents. In 2021 he was appointed Chief Editor of Frontiers in Drug Delivery. He was elected as a Fellow of the Controlled Release Society (2012) and the American Association of Pharmaceutical Scientists (2017). In 2021, he was appointed to the National Research Ethics Committee of Ireland (Clinical Trials A).
Dr. Sahil Malhotra, Postdoctoral Researcher
Dr. Sahil Malhotra is a DevelopMed Postdoctoral Researcher at University College Dublin Ireland. He is working on the Buccal Peptide Delivery project under the supervision of Prof. David Brayden.
He was a former Principal Scientist in R&D in Biocon, one of the leading brands in biopharmaceuticals. Sahil did PhD in Biomedical Enginnering from Indian Institute of Technology Delhi where he developed less immunogenic and advanced nanoparticles based platform technology for personalized cancer therapy. He has more than 7 years of experience in Chemistry, Nanotechnology, Biomaterials Science and Enginnering. Sahil is actively involved in buccal patch design and development and validating their efficacy and Safety in the relevant animal models.
Dr. Muhammad Ijaz, Postdoctoral Researcher
Dr. Muhammad Ijaz, PhD, is a Postdoctoral researcher at the University College Dublin (UCD), bringing over 15 years of academic and professional experience in the field of pharmacy. He earned his doctoral degree in Pharmaceutical Sciences from the University of Innsbruck, Austria. With a profound expertise in pharmaceutical technology, Dr. Ijaz has made remarkable strides in the field of oral drug delivery systems. His pioneering work encompasses the development of mucoadhesive Thiolated cyclodextrin-based transmucosal delivery systems and lipid-based self-nanoemulsifying delivery systems tailored for peptides. Notably, he has also developed a hydrophobic ion pair (HIPs) complexes for hydrophilic peptides, unlocking superior drug loading capacity and augmented permeation through epithelial membranes.
Dr. Ijaz’s contributions span beyond research, extending to mentorship and project management. During his tenure in Pakistan, he managed the successful completion of two funded research projects, showcasing his adept project management skills. Moreover, he has supervision of over 12 M.Phil. and Ph.D. theses, contributing significantly to the academic growth of the pharmacy domain.
Sandeep Karki, PhD. Student
Sandeep Karki is currently pursuing his Ph.D. under the supervision of Professor David Brayden at University College Dublin (UCD) on the design and characterization of a buccal patch for the delivery of therapeutic peptides. His educational background includes a Master in Industrial Pharmaceutical Science from Chung-Ang University, South Korea and B. Pharm from Pokhara University, Nepal. Mr. Karki has +6 years of work experience in drug delivery and formulation research, and he worked at several positions within the capacity of formulation researcher in pharmaceutical companies across South Korea and Nepal.
He has a track record of designing, formulating, and characterizing diverse dosage forms such as conventional solid dosage forms (tablets, capsules), oral films, and long-acting injectables. With a solid pharmaceutical background and involvement in oral drug delivery projects, Mr. Karki is now passionate about exploring formulation strategies aiming to improve peptide delivery via oral route’
Connect with Sandeep here: https://www.linkedin.com/in/sandeep-karki-9ba07254/
Danmarks tekniske universitet
Technical University of Denmark (DTU, www.dtu.dk) is an international elite technical university where education, scientific advice, and innovation rest on a solid foundation of world-class research. DTU’s mission is to develop and utilize natural and technical science for the benefit of society. The University is at the academic and multidisciplinary forefront of the technical and the natural sciences with new initiatives in a number of demanding engineering disciplines, including sustainable energy technology and life science. At DTU, 11.200 students are educating themselves for the future, and 6,000 employees focus each day on education, research, consulting and innovation, which contribute in creating value, welfare, and growth.
Department of Health Technology (DTU Health Tech, www.healthtech.dtu.dk) educates the engineers of the future, and develop new technology and solutions with a vision to improve people’s life before, during and after they are patients. The department’s unique interdisciplinary academic environment with competences in among other things physics, chemistry, biology, mathematics, and computer science support our goal of developing world-class technology, knowledge and innovation in the health area to benefit patients and society.
The DTU team is led by Associate Professor Line Hagner Nielsen, group leader of the Pharmaceutical Technology group at DTU Health Tech. She is the work package leader of WP1 in Buccal-Pep and runs a team of a PhD student and a postdoctoral scientist funded by the EU. The main task of the DTU team is to produce prototypes of the buccal patches in various biopolymeric materials and to in vitro test these prototypes.
Associate Professor Line Hagner Nielsen, Group Leader of the Pharmaceutical Technology group
Dr. Nazanin Zanjanizadeh Ezazi, Postdoctoral Researcher
Eleftheria Pantazoglou, Ph.D. Student
Charite - Universitätsmedizin Berlin
Charité – Universitätsmedizin is one of the largest university hospitals in Europe, which is affiliated with both Humboldt Universität zu Berlin and Freie Universität Berlin. Charitè extends over four campuses and has over 100 different Departments and Institutes. It is internationally renowned for its excellence in teaching and training which is delivered by physicians and researchers of the highest international standard.
Charité –Universitätsmedizin also proudly lays claim to more than half of all German Nobel Prize winners in Physiology or Medicine, including Emil von Behring, Robert Koch, and Paul Ehrlich.
Having marked its 300-year anniversary in 2010, Charité is now one of the largest employers in Berlin.
AdhexPharma is a leading CDMO specializing in the formulation, development, and commercial production of pharmaceutical patches and oral films. With a strong focus on innovation, AdhexPharma leverages state-of-the-art technologies and expertise to provide advanced drug delivery solutions, ultimately improving patient outcomes.
Having a rich history in the pharmaceutical industry for over 40 years, AdhexPharma has successfully collaborated with both startups and renowned companies, as well as various pharmaceutical organizations, on numerous projects. The team possesses extensive experience spanning the entire product lifecycle, from early-stage research and development to regulatory approvals and commercialization. AdhexPharma has a proven track record in managing complex projects, ensuring adherence to timelines, and achieving optimal results.
As a partner in the BUCCAL-PEP project, AdhexPharma provides the consortium with the required knowledge and resources to rapidly translate and test the results of R&D performed in this project to large-scale manufacturing. The company has the GMP pilot lines and test equipment needed to support R&D activities.
Anne-Laure Tedaldi, CMC Development Director
Nicolas Rollet, Head of Formulation
Hugo Vimal, Business Development Manager
Novo Nordisk (https://www.novonordisk.com/) is a global healthcare company, founded in 1923 and headquartered just outside Copenhagen, Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure the diseases we treat. We employ more than 59,000 people in 80 offices around the world, and market our products in 170 countries. At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing and sales – we’re all working to move the needle on patient care.
The Novo Nordisk team is composed of Dr. Stephen Buckley, Dr. Damiano La Zara, Dr. Ragna Berthelsen and post doc (to be hired) from Global Research Technologies (GRT) in Måløv, Denmark. As part of Novo Nordisk’s Research & Early Development (R&ED) organization, GRT plays a central role in realizing our ambition of providing better medicines for patients by turning ideas into drugs, which can ultimately improve the lives of patients with serious chronic diseases. The main tasks of the Novo team is to support the analysis of the utilized NN model compound as well as to contribute to the in vitro and in vivo evaluation of the developed BUCCAL-PEP patch.
Dr. Damiano La Zara, Senior Scientist
Dr. Damiano La Zara is a Senior Scientist in Oral Formulation Research at Novo Nordisk working on developing the next generation of oral therapeutic peptide and protein solid dosage forms. He received his PhD in Chemical Engineering at Delft University of Technology in collaboration with AstraZeneca focusing on controlled pulmonary delivery of inhaled drugs engineered with nanoscale films via atomic layer deposition. After his PhD, he worked as a Scientist at Johnson & Johnson in the Novel Oral Modalities team within Oral Solids Development, where he developed novel formulation concepts for oral delivery of macromolecules as well as supported the clinical development of the oral peptide JNJ-2113, the first oral IL-23 receptor antagonist peptide for moderate-to-severe plaque psoriasis, which is now advancing into Phase 3.
Dr. Ragna Berthelsen, Specialist
Dr. Ragna Berthelsen belongs to in the department of Oral Digitalization and Characterization and works on developing in vitro tools for evaluating oral drug formulations in close collaboration with the Oral Formulation Research team. Ragna has a BSc and MSc in Pharmacy from University of Copenhagen and a PhD in Pharmaceutical Sciences from University of Copenhagen (2014). Her PhD project titled “In vitro models for the prediction of gastrointestinal absorption of poorly water-soluble drugs” focused on exploring in vitro systems to evaluate drug dissolution and permeation. After her PhD Ragna worked as a postdoc and later as Assistant Professor and Associate Professor at University of Copenhagen where she continued her research on in vitro tools to for evaluation of drug formulations and in particular predictive in vitro models simulating drug absorption in the human gastrointestinal tract. Most recently (2022-2023), Ragna worked as a Senior scientist in LEO Pharma within small molecule drug product analytical development.
Cambridge innovation technologies consuling ltd
CITC Ltd, strategically situated in the thriving hub of Cambridge’s biomedical and biotech landscape, fosters innovation in diverse high-tech domains that demand multidisciplinary approaches, spanning from bio-electronics to sophisticated medical solutions. We build robust partnership programs, assist our clients in refining their product supply chains, and oversee an expansive and distinctive portfolio of technologies.
Our team consists of seasoned designers, expert engineers, medical advisors, biologists, material scientists, and project managers, each allocated to projects as technical staff. This structure enables us to effectively and sustainably attain project objectives in a punctual manner while maintaining a precise focus.
Our vision is to pioneer innovation within the realms of healthcare and medicine by strategically repositioning state-of-the-art technologies to enhance people’s quality of life and reduce the cost of care.
Dr. Luigi Occhipinti
Dr Luigi Occhipinti joined the University of Cambridge in April 2014. He developed science and innovation for more than 20 years in emerging technology areas for the post-CMOS roadmap, smart systems heterogeneous integration, polymer and printed electronics, advanced bio-systems and molecular diagnostics, advanced signal processing and nonlinear computation, advanced mechanical, optical and chemical sensor technologies, with focus on miniaturization and advanced packaging technologies for smart devices and products. His current position is Director of Research in Graphene and Related Technologies and he serves as Deputy Director and Chief Operating Officer of the Cambridge Graphene Centre.
His main academic interests include sensors and integrated bio-systems for applications in health care, industrial sustainability, smart wearables and environmental monitoring. Luigi’s research track record encompasses emerging nanomaterials, biocompatible and biodegradable devices and electronics manufacturing on flexible and stretchable substrates, and circular economy.Luigi has authored and co-authored over 130 peer-review papers, 3 book chapters, 2 international standards and is inventor or co-inventor of more than 65 patent applications filed (46 patents granted, 9 as sole inventor). Google Scholar: H-index 26, i10-index 50, Citations >6875
He is co-editor of the Cambridge Elements Series on “Flexible and Large-Area Electronics” published by Cambridge University Press, and Chair of the IEEE International Conference on Flexible and Printable Sensor and Systems (FLEPS) Program. He is also Senior Member of the IEEE society.
Dr. Ioannis Prattis
Dr. Ioannis Prattis began his academic career at Aristotle University of Thessaloniki, where he graduated with a B.Sc. in Biology. He then earned an M.Sc. at Imperial College London before completing his Ph.D. at Queens’ College, University of Cambridge. During his doctoral studies, he was awarded an EPSRC (Engineering and Physical Sciences Research Council) doctoral training partnership scholarship and developed a novel graphene Point-of-Care platform for detecting Polymerase Chain Reaction (PCR) nucleic acid products, and a wearable biosensing platform for stress monitoring. This work reflects his commitment to research and his interest in integrating novel technologies with biology.
On the professional front, Ioannis’s career has encompassed various roles, from developing diagnostic products to serving as an Investment Strategy Intern. Currently, Ioannis is working as a Technical Consultant at CITC, where his role in the Buccal-PEP project is to provide critical insights and evidence-based recommendations to ensure the project can compete effectively in the dynamic and complex healthcare industry. He advises on cost-effective strategies for entering the healthcare market, assesses the economic feasibility of Buccal-PEP’s innovative solution, and helps the project navigate reimbursement and pricing challenges. In addition, Ioannis acts as President & Executive Director of Global Biotech Revolution (GBR), a non for profit global organisation aiming to inspire and develop future leaders in the biotech and healthcare industries.Ioannis’s interests include the commercialisation of novel technologies, assisting organisations in fulfilling their potential, and improving the overall landscape of the biotechnology field.
Catalyze is a Dutch SME specialized in project management and administration for EU-level R&D projects. Catalyze has strong expertise in collaborative academic projects, scientific research, translational research, product development, clinical research, regulatory and commercial strategies in the area of pharmaceuticals, biotechnology, life sciences, and medical devices. Catalyze has experience in project management of international collaborative projects in the field of life sciences, including bookkeeping and administration services including budgeting, (financial) reporting, grant declarations, time keeping (hour registration), invoicing, tax declarations, and personnel affairs. Catalyze also has extensive experience in running R&D projects and employs consultants (PhD, MD) and (financial) administration personnel with unique expertise in this field. Catalyze’s main tasks include: Project Management, assistance in development of a communication strategy, and active communication, dissemination and engagement activities.
Dr. Annika de Jong
Annika de Jong is project manager at Catalyze with an academic background. She has a PhD from Leiden University Medical Center where she worked on a novel RNA therapeutic for the bleeding disorder ‘von Willebrand disease’.
After her PhD she pursued her academic career as Postdoctoral fellow at NYU Langone Health where she focused on the role of RNA granules in atherosclerosis development. While being an academic, she always had a passion for management and organization. This combination she finds as project manager for EU subsidized projects at Catalyze. Her role as project manager for the BUCCAL-PEP project combines best of both the management and the academic world.
Christopher Kruger is a Science Communication Advisor at Catalyze with an academic background. He graduated with an Msc in Human Movement Sciences. His background encompasses various dissemination activities ranging from social media planning, grant proposals, and systematic reviews to presentations.
Within the BUCCAL-PEP project, he is responsible for planning and undertaking dissemination and communication activities such as developing dissemination and communication plans, facilitating the project’s End-User Advisory Board, engaging with stakeholders, and drafting copy for all project audiences.